Recent guidance from the Royal College of Physicians that says doctors should only use medical apps carrying a CE mark has come under fire from Charles Lowe, managing director of the Digital Health and Care Alliance.
Lowe, who is also president of the telemedicine and e-health section council of the Royal Society of Medicine, posted a blog response suggesting that the guidance would discourage doctors from using smartphone apps that can improve efficiency and patient outcomes.
Lowe’s main concern is that the guidance “places the onus of deciding whether an app is a medical device on individual clinicians, a decision that at times even experienced MHRA [Medicines and Healthcare Products Regulatory] personnel can equivocate on.”
The guidance, which was published on 29 April, was developed by the RCP in consultation with MHRA and the General Medical Council.
It says that any healthcare app that can be classed as a medical device, such as apps used to diagnose, support diagnosis or clinical decisions, should carry a CE mark to show it complies with EU safety, health and environmental requirements.
For Lowe, this guidance goes too far, writing that despite a “few bad eggs”, the vast majority of medical apps “fulfil a useful purpose”.
“It would therefore be a disaster if this advice resulted in the wholesale abandonment of their use – that would undoubtedly contribute to a significant worsening of the current NHS crisis.”
Speaking to Digital Health News, Lowe backed his point by commenting that at a recent meeting he attended two people from the MHRA were not confident enough to determine whether a piece of simple telehealth technology was a medical device or not.
“I’m quite sure that sat down with all information and requirements they could have come to a decision, but the point is there is no sharp division on when something is no longer a medical device,” he said.
“We shouldn’t expect doctors to have to decide what needs CE certificate. It is a terrific ask. And the danger is doctors are concerned about legal liability.” He added: “Hopefully I’m being completely overcautious and that nothing actually happens.”
In his blog post Lowe suggested an alternative approach for safe-checking by setting a date for apps used in the NHS to be checked using the ISB0129 standard, a clinical risk management standard created by the Information Standards Board for Health and Social Care for health IT systems in the UK. This process could then determine what apps need CE certification.
“After that date – set at a sensible time in the future – only ISB0129-approved, and where appropriate CE certified apps, should be allowed to be used,” writes Lowe.
He also says the DHACA is working actively with NHS England, the Health and Social Care Information Centre and other bodies on the development of a system to recommend apps for NHS use, as outlined in the 'Personalised Health and Care 2020 Framework'. Proposals on this process are due to be published in June.